There are about 10460 clinical studies being (or have been) conducted in Australia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Background. For more than a century a causal link between influenza and cardiovascular disease has been suspected. It is conceivable that influenza may precipitate plaque rupture, increase cytokines with central roles in plaque destabilization and trigger the coagulation cascade. Accordingly, registry studies, case control studies and a few small randomized trials, all underpowered for clinical endpoints, have demonstrated that the risk for acute myocardial infarction (AMI) is increased following respiratory infection and that the risk of stroke and AMI in patients with established cardiovascular disease seem to be reduced following influenza vaccination. In May 2015 a Cochrane review concluded that influenza vaccination may reduce cardiovascular mortality and cardiovascular events but bias and inconsistent results in prior studies require higher-quality evidence to confirm these findings. High costs and little commercial interest in conducting a randomized trial on influenza vaccine in cardiovascular disease stand in the way. Objective. The objective is to document whether influenza vaccination protects against cardiovascular events and death in patients with an AMI or very high risk stable coronary artery disease patients. Methods. Population: 4400 patients with ST-elevation (STEMI), non-ST elevation myocardial infarction (NSTEMI) or very high risk stable coronary artery disease are randomized 1:1 in a blinded fashion using an RRCT design and followed up via registries and telephone calls. Intervention: Influenza vaccination. Control: Placebo (saline). Outcome: The primary endpoint is a composite of death, myocardial infarction and stent thrombosis till 1 year. Patients will be included in the study in all of Sweden's 7 university hospitals and 5 general hospitals, 4 university hospitals and 1 general hospital in Denmark, in 1 specialized heart center in Norway, 2 university hospitals in Czech Republic, 6 hospitals in Scotland, 1 university hospital in Latvia and 2 hospitals in Bangladesh. Secondary endpoints are time to all-cause death till 1 year, time to cardiovascular death till 1 year, time to stent thrombosis till 1 year, time to revascularization till 1 year, time to myocardial infarction till 1 year, time to cardiovascular death, a new myocardial infarction or stent thrombosis (first occurring) till 1 year, time to stroke, including TIA till 1 year, time to rehospitalization for heart failure till 1 year, time to hospitalization for arrhythmia till 1 year or length of hospital stay (if information is available). From a hypothesis generating perspective we aim to follow up patients through registries beyond 1 year and up to 5 years. The trial has been approved by the ethical committee system (Dnr 2014/264) and the Medical Products Agency (EudraCTnr -2014-001354-42) in Sweden. Perspectives. If a clinical benefit can be demonstrated in this prospective trial influenza vaccination may become an important novel in-hospital therapy for patients with cardiovascular disease and the accompanying direct and indirect societal gains will be profound.
The purpose of this study is to evaluate the current state of nutrition care and patient related outcomes in patients with head, neck and esophageal cancers in North America, Europe and Australia.
Thoracolumbar (TL) burst fractures in neurologically intact patients account for approximately 45% of all TL spine injuries. Despite being common fractures, there is significant variability in treatment recommendations encompassing surgery and non-surgical treatment options. The controversy regarding optimal treatment for these injuries is fueled by several studies which suggest a potential benefit to surgical treatment in the realm of patient satisfaction, and the overall socio-economic burden of treatment while other studies demonstrate improved outcomes and lower morbidity with non-surgical treatment. This study aims to perform a prospective cohort analysis investigating the clinical outcome of various treatment alternatives for patients with A3/A4 fractures in the thoracolumbar region. A cost-effectiveness analysis will also be performed to identify costs and benefits of each treatment option. More specifically a sub-group analysis will be performed for this group of patients, which have equipoise in regards to patients treatment, as decided by a blinded review panel.
Characterize the safety, tolerability, ECG effects, pharmacokinetics and immunogenicity of anetumab ravtansine given as single agent and after inhibition of CYP3A4 and P-gp by concomitant administration of itraconazole in subjects with mesothelin-expressing advanced solid cancers
This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome.
This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.
An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country study in participants with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 (Day 1 up to Week 16) is designed to compare the achievement of minimal disease activity (MDA) between participants randomized to either adalimumab in combination with methotrexate (MTX) or MTX alone escalated to the highest recommended or tolerable dose; Part 2 (Week 16 through Week 32) is designed to evaluate the maintenance or achievement of MDA on 4 different treatment regimens using adalimumab and/or MTX, with participant allocation based on the initial randomized treatment and achievement of MDA in Part 1, and with rescue treatment option.
Acute pancreatitis (AP) in children has an increasing incidence and is at times associated with significant morbidity and mortality. Despite this, there is no high-quality evidence-based treatment for childhood AP and current practice is based entirely on historical approach and extrapolation from adult studies. In this study, we evaluate the use of early enteral feeding in children with AP. The traditional approach to treating AP relies on fasting and intravenous fluids (or occasionally parenteral nutrition) assuming that this minimizes stimulation of an already inflamed pancreas. Contrary to this, evidence exists that early feeding of patients with AP may be beneficial. Randomized controlled trials of fasting vs. early oral diet in adult patients with mild AP, showed no differences in pain, serum amylase and CRP levels, but also shorter hospital stay in those fed earlier. Further data in adults with severe AP demonstrated that early enteral nutrition was associated with decreased mortality, infections and multiorgan failure. These benefits were lost if enteral nutrition was commenced 48 hour after admission. Suggested explanations for these findings include the possibility that enteral nutrition may maintain integrity and function of intestinal mucosa and reduce gut-origin sepsis. Historically, nasojejunal (NJ) feeds were felt to be safer than oral or nasogastric feeds in the setting of AP by avoiding cephalic and gastric pancreatic stimulation. NJ feeds require moderately invasive tube insertion under radiographic or endoscopic guidance. Recent data suggest that oral feeding with a low fat diet was as safe as NJ feeding. Several animal models of AP demonstrate that the exocrine pancreas is resistant to cholecystokinin (CCK) stimulation after the onset of AP, suggesting a mechanism for the lack of concern of exacerbating pancreatitis with enteral feeds. Considering this data it is less certain that diet and fat restriction contribute to treatment of AP. To further challenge the prior conceptions of AP management it is necessary to explore the use of unrestricted diet (full fat) in mild-moderate pediatric AP, a population with recognized low complication risk. Despite the mounting evidence to the contrary, it is still standard clinical practice to fast children with AP, and only slowly reintroduce feeds depending on the clinical improvement. This is largely due to the lack of clinical interventional studies in children with AP.
The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.
This is a Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the statistical equivalence of efficacy, safety and immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in asymptomatic patients with Low Tumor Burden Follicular Lymphoma.